Medical Device Standards Supported By IAS
Several
management standards are applicable to manufacturing of Medical equipments and
devices. A brief overview of the most relevant, also information about the role
IAS
(ISO 13485 Certification provider in
Singapore) can play in getting your organization certified.
What are the common medical device manufacturing standards?
The most common medical device manufacturing standards include:
·
ISO
9001:
This
is the general standard for quality management. It isn't industry-specific and
as such can be effectively adopted by any organization that wishes to implement
a more rigorous system based on a continuous improvement cycle. For Medical
equipments and devices manufacturers, ISO 9001 engages management in the
quality control process, helping make organization-wide changes that keep costs
down, improve accountability, facilitate growth in a more responsible way and
simplify regulatory compliance. The most recent version of ISO 9001, published
in 2015, is based on the high-level Annex SL directive, utilizing a common
vocabulary and structure that makes it simpler to attain compliance with other,
more specific standards.
·
ISO
13485:
This
is the quality management system specifically designed for Medical equipments
and devices manufacturers. It expands on and refines the framework established
by ISO 9001, with the aim of harmonizing regulatory requirements. Compliance
with ISO 13485 Certification assists with overall quality control,
traceability, process validation and risk management. Manufacturers that attain
ISO Certification for Medical Devices in
Singapore compliance will have an easier time carrying their products
to global markets. Compliance can also streamline your processes and ultimately
help you to run a progressively efficient, beneficial and risk-averse
operation. There are many ISO 13485 Certification
Services in Singapore who can help you to achieve ISO Certification for Medical equipment in Singapore.
·
ISO
14001:
Sustainability
is an important concern for all manufacturers trying to run a leaner business.
Implementing an environmental management system compliant with ISO 14001 standards
can help medical device manufacturers cut down on waste, conserve energy and
reduce their overall carbon footprint — important benefits when working with
complex global supply chains. Like ISO 9001:2015, the latest version of ISO
14001 is based on the Annex SL structure. As an outcome, if you already have a
certified quality management system in place, adopting ISO 14001 can be
relatively straightforward. When your environmental, health and safety, and
other protocols share necessities, your business is better positioned to
succeed in the competitive medical device industry.
·
ISO
50001:
This
standard complements ISO 14001 by offering a particular standardized system for
energy management. With it, Medical equipment and device manufacturers can
reduce their operating expenses and improve their overall energy efficiency,
which can subsequently enhance their reputation and facilitate regulatory
compliance.
·
OHSAS
18001 / ISO 45001:
Pharmaceutical
and medical device manufacturing often presents specific occupational risks,
especially when working with the advanced technology found in imaging equipment
and other products. While ensuring the safety of your team is essential, it
shouldn't come at the expense of productivity. OHSAS 18001 / ISO 45001 outlines
requirements for occupational health and safety management systems that can be
utilized in the medical device industry to reduce risk and improve
accountability while positioning your organization for sustainable growth. Use
it to diminish accident rates and related liability issues on an ongoing basis.
·
ISO
27001:
As
medical devices become progressively sophisticated, cyber security is an
expanding concern. The developing market for smartphone based health monitoring
apps, as well as connected devices in the diagnostic room and operating
theatre, requires proactive information security standards. Add to that the
danger of your valuable intellectual property being compromised in a data
breach, and it is clear to see why ISO 27001 has turned into a critical standard
for health care and medical device manufacturers. ISO 27001 contains tools that
can help you assess and manage cyber security risks in your organization. It is
based on a set of globally recognized best practices that aren't specific to
any one platform or software package. Becoming ISO 27001 certified will
position you to adapt accordingly as the threats against your enterprise change
and to maintain continuity in the event of a cyber-security incident.
ISO 13485 Quality Management System certification
Evolving
in the Medical Device field calls for a level of understanding of the
regulatory environment and what it suggests for duties and obligations.
Countries
are increasingly developing their local regulations based on the GHTF (Global
Harmonization Task Force, now the International Medical Device Regulator’s
Forum - IMDRF) model.
Already-existing
regulatory schemes tend to be assessed by Health Authorities controls and/or
Certification Bodies.
The
majority of these regulations have as common base the Quality Management System
(QMS) and Risk management principles. ISO 13485, in its recent evolution
affirms that the regulatory requirements are intended to be a key consideration
in the future of Quality Management Systems.
What is the ISO 13485 standard?
ISO
13485, Medical devices - Quality Management Systems necessities for regulatory
purposes, is an globally recognized standard for organizations engaged with the
medical device industry. Companies are utilizing compliance to this standard to
get the certification of their Quality Management System. The main purpose of
the ISO 13485 standard is the Harmonization of the Medical Device regulatory
requirements for Quality Management Systems. The survey conducted by the
International Organization for Standardization (ISO) shows that in 2015, the
quantity of ISO 13485 certificates issued worldwide was 26255. ISO
13485 Certification Services in Singapore provide ISO
accreditation necessitates that the organization occasionally reviews
its quality procedures.
Who
can be ISO 13485 certified?
The
ISO 13485 certification is a proof
of Quality Management System compliance to the standard for organizations
engaged in the Medical Device industry. This approach is not only followed by
Medical Device Manufacturers but also supporting organizations such as
Subcontractors, Suppliers, European Authorized Representatives, specialized
Consulting firms etc.,.
Note
that ISO 13485:2016 expands the profile of companies and organizations to which
the standard can apply: Organizations engaged in one or several stages of
a Medical Device Lifecycle or a Supplier or other External Parties providing
such organizations with products for example.
Organizations involved
in one or more phases of the medical device life cycle
- Design
and Development
- Production
- Storage
- Distribution
- Installation
- Servicing
Suppliers or External
Parties who provide products to such Organizations
- Raw
materials
- Components
- Sub-assemblies
- Medical
devices
- Sterilization
services
- Calibration
services
- Distribution
services
- Maintenance
services
In
addition, the ISO 13485 standard requires that the organization recognizes its
roles in connection with the regulatory requirements (e.g. Manufacturer,
Representative, Importer and / or Distributor), and determines the applicable
regulatory requirements depending on the role(s), then integrates the
regulatory requirements in the QMS.
A
Quality Management System is neither intended to be a frozen in time nor is the
company. The QMS is defined to help streamline and reinforce internal processes
and procedures while carrying on with the changes and evolutions affecting the
market.
How is ISO 13485 recognized worldwide?
ISO
13485 focuses on the harmonization of the Quality Management Systems in the
framework of Medical Device regulatory necessities. It isn't surprising to see
that many jurisdictions recognize or even require that Medical Device
manufacturers obtain ISO Certification for Medical equipment in
Singapore in order to access their market. Various regulatory
authorities have adopted the ISO Certification
for Medical Devices in Singapore standard as part of their own requirements
to enable the sale of Medical Devices on their territory. The Medical Device Single
Audit Program commonly referred to as MDSAP went a step advance: it is built on
the ISO 13485 principles and incorporates those principles as feature of the
audit criteria.
Why
should I get ISO 13485 certified?
Voluntarily
conforming to ISO 13485 is the best approach that companies have to prepare for
an international market access. Being ISO 13485 certified provides stakeholders
and business partners with the confidence that the organization has put all the
efforts to conform to the standard.
Very useful information..
ReplyDeleteISO 45001 Lead Auditor Training Online